NCT02770066 A Prospective Danish National Registry of PTRA in Patients With Renovascular Hypertension
| NCT ID | NCT02770066 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Renal Artery Obstruction |
| Study Type | OBSERVATIONAL |
| Enrollment | 160 participants |
| Start Date | 2015-01-01 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 160 participants in total. It began in 2015-01-01 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A prospective Danish national registry of percutaneous transluminal renal angioplasty (PTRA) in high-risk patients with renal artery stenosis selected on the basis of common national criteria, and with a common follow-up protocol for all three Danish centres offering PTRA
Eligibility Criteria
Eligibility criteria 1. True resistant hypertension (≥ 3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses) and uncontrolled blood pressure confirmed by 24-hour ambulatory blood pressure monitoring. The 24-hour ambulatory blood pressure monitoring is performed after nurse-administered medication and blood pressure measurements are performed hourly. If the average 24-hour ambulatory systolic blood pressure is ≥ 130 mmHg the patient can be evaluated for renal artery stenosis. 2. Hypertension and intolerance or side effects of the antihypertensive treatment. Hypertension is confirmed by 24-hour ambulatory blood pressure monitoring. The 24-hour ambulatory blood pressure monitoring is performed after nurse-administered medication and blood pressure measurements are performed hourly. If the average 24-hour ambulatory systolic blood pressure is ≥ 130 mmHg the patient can be evaluated for renal artery stenosis. 3. Progressive renal insufficiency (a reduction in eGFR \> 5 ml/min/1,73 m2 per year) in patients with bilateral renal artery stenosis or in patients with renal artery stenosis and only one kidney. 4. Recurrent heart failure/pulmonary edema and resistant hypertension (≥ 3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses) that may not be attributed to non-compliance, reduced left heart ventricular ejection fraction/heart valve disease or other obvious explanations (atrial fibrillation, fever, hyperthyroidism etc.). If the average 24-hour ambulatory systolic blood pressure is ≥ 130 mmHg after nurse-administered medication the patient can be evaluated for renal artery stenosis. 5. Younger patients (\< 40 years) with hypertension (24-hour ambulatory blood pressure monitoring ≥ 130/80 mmHg after nurse-administered medication ) Inclusion Criteria: All of the following: 1. At least one of the above eligibility criteria 2. Duplex doppler ultrasonography or renography investigations consistent with hemodynamically significant renal artery stenosis 3. CT angiography or renal arteriography with angiographic renal artery stenosis of ≥ 70 % reduction of the luminal diameter in at least one projection Exclusion Criteria: 1. If angiography/arteriography, ultrasonography or renography is consistent with bilateral significant renal artery stenosis and only one side is treated with PTRA 2. PTRA of a renal artery supplying a kidney which pre-PTRA handles ≤ 10% of the total kidney function (with no blockage of the renin-angiotensin system) and has a kidney size \< 7 cm (length)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT02770066 clinical trial?
This trial is open to participants of all sexes, studying Renal Artery Obstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02770066 currently recruiting?
Yes, NCT02770066 is actively recruiting participants. Contact the research team at m.reinhard@dadlnet.dk for enrollment information.
Where is the NCT02770066 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aarhus N, Denmark, Glostrup Municipality, Denmark, Holbæk, Denmark and 1 additional location.
Who is sponsoring the NCT02770066 clinical trial?
NCT02770066 is sponsored by University of Aarhus. The trial plans to enroll 160 participants.